FederalOpenFixed dateFood and Drug Administration

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Award ceiling
up to $900,000
Closes
May 16, 2028
Last verified
2026-10-16

Awards up to $900,000 per recipient for others (see text field entitled "additional information on eligibility" for clarification), closing May 16, 2028.

Official pageSign in to trackVerified2026-10-16
Others (see text field entitled "Additional Information on Eligibility" for clarification)AgricultureConsumer ProtectionFood & Nutrition

In one sentence

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required) awards up to $900,000 per recipient, open to others (see text field entitled "additional information on eligibility" for clarification), closing May 16, 2028.

Record fields
Program pool (total)
Not confirmed
Total across all awards in this programme. Not an amount any single applicant can receive.
Award ceiling (per project)
$900,000
Award floor
Not stated
Typical award
Not confirmed
Deadline
May 16, 2028
Deadline type
Fixed date
Opens
Jul 11, 2025
Status
Open
Eligible entities
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Geography
Not stated
Matching funds
No
Disbursement
Not confirmed
Application effort
Not confirmed
Use of funds
clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions
Currency
USD

How much money is available?

Two different figures govern a programme and they are not interchangeable. The programme pool is what the funder has allocated across every award it will make this cycle. The award ceiling is the most one applicant can be granted.

Program pool (total)Across all awards this cycle
Not stated
Award ceiling (per project)The most one applicant can receive
$900,000

Who can apply?

level
federal
Derived from the source that published this record
entity
Others (see text field entitled "Additional Information on Eligibility" for clarification)
Source field: entity types
industry
use
clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions
Source field: use of funds
size limit

Not confirmed

Source field: applicant size limit
clause text

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status…

We store the structured fields above. Clause-by-clause text from the guidelines is not connected for this record.

When does it close?

May 16, 2028578 daysDeadline type Fixed date
Sign in to be reminded before this closes

What can the money be used for?

1 categoryThe source’s own spending categories, and what is not parsed.
clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions

These categories come from the source's own classification. A line-item cost table, where the programme publishes one, lives in the guidelines and is not parsed for this record.

How hard is the application?

1 fieldEffort, match requirement and reimbursement, as the source stated them.
Application effort
Not confirmed
Disbursement
Not confirmed
Matching funds
No

What comparable notices state

64 recordsStated ceilings on open records in the same industry.

Among open records stored under Agriculture, 64 of 78 state an award ceiling. Those that do run:

  • 25th percentile$300,000
  • Median$1,000,000
  • 75th percentile$2,000,000

A statistical estimate, not a prediction. It describes what a set of notices has published in this catalogue on the day you read it, and says nothing about what this programme will award. Records stating no ceiling are excluded rather than counted as zero, and the programme pool — what a funder has across every applicant — is a different column and is never mixed in.

Who has won this programme before?

1262 awardsAwards under the same assistance listing, not under this notice.

1262 federal awards on file under assistance listing 93.103, the programme this notice is published under. These are not awards made under this notice — a listing covers every year the programme runs, and awards under an open notice do not exist yet.

Every award under this programme

Common questions

5 questionsEvery answer is a stored field from this record. Questions the source did not answer are not asked.
How much can one applicant receive?
Up to $900,000 per recipient.
When is the application deadline?
May 16, 2028.
Who is eligible to apply?
Others (see text field entitled "Additional Information on Eligibility" for clarification).
What can the funding be used for?
clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions, as classified by the source.
Is matching funding required?
No. The source states that no matching funds are required.

AI summary of the source text

Optional. Every core field on this record is already above, free and complete.

AI summary of the source text

Studio reads this record’s stored eligibility and materials text and breaks it into separate points, each quoting the exact words it came from. It never writes application prose, never guesses at a field the source did not state, and never estimates anyone’s chances.

Included with Studio

Sign in

What else is open

Also open under assistance listing 93.103

A listing names the programme; a notice names one round of it. These are other rounds open now, not other years of this one.

Provenance
Source pagegrants.gov
Retrieved2026-10-16
MethodAutomated check
First seen2026-09-01
Assistance listing93.103

The official page governs. If the source and this record disagree, the source is correct — programmes change their terms between our checks, so confirm every figure above before you apply.